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Friday, May 24, 2024

NurExone Unlocks Several Milestones Since March 2024 (TSXV: NRX, FSE: J90, NRX.V)

● Leading the charge in exosome-based medicine, NurExone pioneers ExoTherapy, utilizing tiny cell-secreted particles to deliver treatments like ExoPTEN, focusing on spinal cord injury recovery — a breakthrough recognized by the FDA with Orphan Drug Designation.

● March 2024 marked a significant leap as NurExone ventured into animal experiments, a crucial step in the preclinical testing phase for FDA approval of ExoPTEN. This follows constructive dialogue with the FDA, indicating progress toward human clinical trials slated for 2025.

● NurExone recently closed a $4 million deal through the exercise and expiration of warrants, demonstrating investor confidence and providing vital funds to propel research and development efforts forward.

NurExone (TSXV:NRX, OTC:NRXBF) is a biotech company specializing in Spinal Cord Injuries (SCI) that holds significant potential for investors. Why? Firstly, let me explain. With its robust pipeline portfolio, rapid advancement, and strong analyst projections, NurExone is positioned for success. While the current share price hovers around $0.60, Litchfield Firms, a reputable research entity, has set a price target of $4.00 for NurExone’s shares! It’s evident that the company is credible, and disregarding this opportunity would be akin to fumbling a pass from Tom Brady. Don’t let this chance slip through your fingers; the Super Bowl victory is within reach.

What is Behind NurExone’s Future Success? 

Exosomes, tiny cell-secreted particles, are big news in medicine for their ability to carry healing treatments. NurExone (TSXV:NRX, OTC:NRXBF) is at the forefront, using exosomes to create ExoTherapy, a cutting-edge way to deliver drugs. Their star product, ExoPTEN, targets healing and recovery in people with spinal cord injuries, a breakthrough that even the FDA recognizes with Orphan Drug Designation, a special status for crucial treatments.

NurExone’s ExoTherapy isn’t just a lucky guess—it’s the result of years of hard work and smart research. By tapping into the power of exosomes, they’re making sure treatments hit the right spots, improving outcomes for patients. Plus, they’ve got the exclusive rights to top-notch research from prestigious institutions like the Technion – Israel Institute of Technology and Tel Aviv University. It’s no wonder they’re leading the pack in exosome-based medicine.

Since early March, the company entered into another whole dimension with significant updates:

On March 1, 2024, the Company began setting up its own labs and offices to boost its research and development efforts, after finalizing lease and construction deals. These initiatives are expected to be finished by the end of June 2024.

Then, on March 22, 2024, the company announced its involvement in animal experiments conducted by a Contract Research Organization (CRO). This is part of the preclinical testing phase for an Investigational New Drug (IND) application to the FDA. The goal is to evaluate the safety and effectiveness of the ExoPTEN drug before moving on to clinical trials with humans, which are planned to start in 2025. This engagement follows a Pre-Investigational New Drug (“Pre-IND”) meeting with the FDA, where the manufacturing, preclinical, and clinical development plan for ExoPTEN, NurExone’s first ExoTherapy product, was discussed and a written response from the FDA was received.

Here is what Dr. Lior Shaltiel, CEO of NurExone said:

“Our emphasis on research and development in 2023, coupled with the expansion of our Intellectual Property (“IP”) portfolio, the ODD for ExoPTEN, and the growth of the ExoTherapy platform, are laying the groundwork for the accelerated introduction of minimally invasive regenerative medicine.”

Eran Ovadya, CFO of NurExone, also said:

“Due to the ongoing support and confidence of our investors, the Company is confident that its current total existing funds, augmented by the recently completed exercise of warrants, will support ongoing operating activities through the end of 2024.”

Ovadya mentioned warrants and funds. But how are they? 

Nurexone closed $4M thanks to its warrants 
NurExone (TSXV:NRX, OTC:NRXBF)  recently finalized the exercise and expiration of its common share purchase warrants, originally issued in a June 2022 private placement. After meeting predefined criteria outlined in a September 28, 2023 press release, 9,684,993 warrants were exercised, yielding C$3,680,297 in gross proceeds. Additionally, 2,997,347 warrants expired unexercised.

In parallel, NurExone saw gross proceeds of C$276,591 from the exercise of warrants not subject to acceleration. These proceeds originated from two distinct groups: 556,818 warrants from a September 2023 private placement with an exercise price of C$0.34, and 181,818 warrants from another September 2023 private placement with an exercise price of C$0.48. This strategic maneuver reflects NurExone’s commitment to optimizing shareholder value and seizing favorable market conditions.

Expenses and Funds

In 2023, research and development (R&D) expenses totaled US$1.54 million, up from US$1.39 million in 2022. This increase of US$0.15 million was primarily due to extensive efforts in developing ExoPTEN technology and other siRNA targets.

General and administrative (G&A) expenses were US$2.12 million in 2023, down from US$4.15 million in 2022. The decrease of US$2.03 million was mainly due to reduced professional services related to the transition to a listed public company in 2022.

Listing expenses were absent in 2023, compared to US$2.08 million in 2022, associated with a reverse takeover transaction.

Financial income/expenses, net, shifted from an expense of US$0.55 million in 2022 to income of US$0.02 million in 2023, primarily due to non-cash expenses related to warrant and royalty liability valuation in 2022.

The net loss decreased to US$3.64 million in 2023 from US$8.17 million in 2022, with reductions in G&A and listing expenses being key factors.

As of December 31, 2023, the company’s cash and equivalents stood at US$0.54 million, down from US$2.46 million in 2022. This decrease was primarily due to net cash used in operating activities, partially offset by proceeds from private placements and a grant from the Israeli Innovation Authority.

Additionally, the company secured US$1.20 million in restricted cash as of December 31, 2023, associated with a private placement completed in January 2024.

NurExone is currently in the dynamic stages of research, development, and expansion. While we haven’t introduced any products to the market or generated significant revenue yet, we’re actively working towards those goals. We’re optimistic about our future and are committed to achieving profitability. To support our endeavors, we will continue to explore opportunities for financing through equity or debt until we reach our objectives.

What to remember about NurExone

NurExone (TSXV:NRX, OTC:NRXBF)’s pioneering ExoTherapy, anchored by the groundbreaking ExoPTEN, marks a significant leap forward in medical innovation, particularly in spinal cord injury treatment. Recent milestones, including the establishment of in-house facilities and engagement in preclinical studies, underscore the company’s commitment to advancing its therapeutic platform.

Financially, NurExone’s successful warrant exercise, securing $4 million, highlights investor confidence in its trajectory. Despite fluctuations in expenses and net losses, strategic maneuvers and prudent financial management position the company for sustainable growth.

Looking ahead, NurExone remains focused on transformative therapies, guided by a dedicated team and strategic partnerships. As it continues to navigate the complexities of biotech development, NurExone’s unwavering commitment to research, innovation, and financial sustainability ensures a promising future in advancing regenerative medicine for patients globally.

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